Infant Ventilation Devices

The use of manual or mechanical devices to provide assisted breathing to infants can be a lifesaving and life-changing event, whether during emergency resuscitation or longer-term respiratory support. Mortality in this group is largely due to respiratory failure, complicated by cascading lung injury induced by this intervention. Research on mitigating injury by differing methods and technologies of breathing support is mostly focused on preterm infant weights < 2kg and in a limited...
More Description

The use of manual or mechanical devices to provide assisted breathing to infants can be a lifesaving and life-changing event, whether during emergency resuscitation or longer-term respiratory support. Mortality in this group is largely due to respiratory failure, complicated by cascading lung injury induced by this intervention. Research on mitigating injury by differing methods and technologies of breathing support is mostly focused on preterm infant weights < 2kg and in a limited range of devices. The objective of this thesis is to examine the biomechanical performance of different types and brands of infant ventilation devices across the wide weight range (450gms to 10kg), and lung physiology/disease states that they are required to perform. The role of International Standards and medical device regulators in informing manufacturers about minimum safety and performance were also examined, as these are integral to the capacity of devices to deliver safe ventilation to the cohort. A range of devices was tested with experienced clinicians simulating resuscitation using manikin and bench test lung models. Results revealed inherent design flaws, poor performance, and critical safety issues in some of the most common devices used worldwide to ventilate infants. Serious shortcomings in the International Standards relating to the basic safety and performance characteristics for infant ventilation were exposed. Reliance by medical device regulatory authorities on compliance with these standards as an indication of an efficacious device is ill-advised. Inadequacies in ventilation device design or their clinical application, often undetectable to the user, can cause lifelong respiratory and neurodevelopmental complications. Future development of improved device testing models encompassed in revised International Standards will have a real impact in reducing poor outcomes after receiving this lifesaving intervention.